DALAN GOLDEN TROPICS ANTIBACTERIAL DEODORANT - triclosan soap
Dalan Kimya Endustri A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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dalan GOLDEN TROPICS antibacterial soap deodorant soap

Active Ingredient / Purpose

Triclosan 0.1% ...... Antibacterial

Uses

Antibacterial Soap

Warnings

For external use only
Do not use

this product on infants under 6 months of age.
in the eyes. If contact occurs, flush eyes with water.

Stop use and ask a doctor if irritation and redness develops or if condition persists for more than 72 hours.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Lather over wet skin and rinse well

Inactive Ingredients:

Sodium Tallowate, Sodium Palmate, Water (aqua), Sodium Palm Kernelate, Fragrance, Sodium Chloride, Alkyl Lactate, Glycerin, Pentylene Glycol, PEG-40 Hydrogenated Castor Oil, Trideceth-9. Nonfat Dry Milk, Carica Papaya (Papaya) Fruit Extract, Magnifera Indica (Mango) Fruit Extract, Macadamia Ternifolia Seed Oil, Fructose, Cocamide DEA, Tetrasodium EDTA, Etidronic Acid, Limonene, Linalool, Hexyl Cinnamal, Benzyl Salicylate, Geraniol, Eugenol

Package Labeling

GoldenTropics90gLabel

GoldenTropics125gLabel

DALAN GOLDEN TROPICS ANTIBACTERIAL DEODORANT
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51209-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
TRIDECETH-9 (UNII: X9HD79I514)
SKIM MILK (UNII: 6A001Y4M5A)
PAPAYA (UNII: KU94FIY6JB)
MANGO (UNII: I629I3NR86)
MACADAMIA OIL (UNII: 515610SU8C)
FRUCTOSE (UNII: 6YSS42VSEV)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONIC ACID (UNII: M2F465ROXU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GERANIOL (UNII: L837108USY)
EUGENOL (UNII: 3T8H1794QW)

#	Item Code	Package Description
Packaging
1	NDC:51209-002-00	3 in 1 BOX
1		90 g in 1 PACKAGE
2	NDC:51209-002-01	3 in 1 BOX
2		125 g in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/06/2014

Labeler - Dalan Kimya Endustri A.S. (566219285)

Name	Address	ID/FEI	Business Operations
Establishment
Dalan Kimya Endustri A.S.		566219285	manufacture(51209-002)